~
Pathology law threatens practices Andrew Bracey PRACTICES could go out of business as a result of soaring costs if legislation governing leasing arrangements with pathology and diagnostic imaging providers comes into force. From I March, changes to the Health Insurance Act will mean practices deemed to be charging a~ market value for colocated services could face fines of up to $660,000 or five years in jail. Practices could be required to provide evidence to Medicare
that the rent they are charging is within 10% of acceptable market values. This would be determined by taking the average of evaluations by at least two independent valuers and comparing it to the cost charged. Practice management consultant David Oahm told Medical Ol>server this would create additional costs for practices with legal fees and leases having to be changed. "This could affect how much GPs are paid, reduce bulk-billing and push up patient fees, •
he said. Australian Association of Practice ManagetS (AAPMJ vice president Brett McPhetSOn said this could ultimately "jeopardise the viability of general practice services."
The AMA lodged a submission to the government expressing concerns about the legislation last week. The submission said it "should be up to the courts, not government, to determine if the rent paid by any party is grossly excessive or grossly undervalued so as to result in the provision
of an incenti~ to refer or provide. "The effect of this govetnmental price fixing will be to create an environment where pathology providers increase their net profits by obtaining cheaper rents than the free market provides. "More than likely [this] will discourage the co-location of medical services with pathology or diagnostic imaging services which would be in direct conflict with the government's proposed policy to improve access to a >page 4
GPs reject accreditation Andrew Bracey GPs are shunning practice accred· iration and forgoing incentives of up to $56,000, with government figures revealing as many as one in three general practices have refused to take it up. A Commonwealth report revealed just 65.7% of practices were accredited in 2007 - much lower than previous estimates from Australian General Practice Accreditation Limired (AGPAL) of 90 per cent. The latest Review of Government Services Provision report was bas~d on practice
numbers supplied by individual divisions which indicated there were 7356 general practices in Australia. It used accreditation figures from AGPAL and, for the first time, Quality Practice Accreditation. AGPAL told Medical Observer it would not challenge the report
and in light of the discrepancy would have to "revise" its numbers. Dr joe Kosterich, a Perth GP and former AMA Council of General Practice chair who lobbied against the introduction of accrediration on behalf of the profession, said the new figure meant practices refus· ing to accredit could no longer be ignored. "If one in three have decided by this stage they don't see it as worth· while going through, it means [the accrediration bodies! or tbe college need to actually engage with them and find out what they see as the problem so improvements can be made.•
ON DEEPER PALPATION Poverty is linked to physiological stress 23
The cost of accreditation cur-
rently starts at around $1100 per full·time equivalent GP, and govern· ment figures show that in 2005..()6 practices taking part in the Practice Incentives Program (PIP) received average payments of $56,000. >page 4
REAL CASES Send in your story and win $300
29
rosuvastatin A. Astralenea Ply Ud. ABH 54 009 682311. Almo Road, Nor11i Ryde AstraZeneca'Z HSW 2113. CRESTOfl is • hdrsnark rJ !he AstraZenea Group. tnroec1 ~om Slilalogi &Ul.lld,
Osaka...,.
OJ,W ASTHICo/llliCI
~ contactus
'--'
Co Editon
Deana Henn, Simon Wooldridge Medlell Editor Or libby Hams, MBBS, FRACG.P NewsDIBrad Mclean Polltleal News Editor Sophie Blakemore
RACGP accused of power play Andrew Bracey
control. They could contest
MOVES by the RACGP to
the certification decisions
extend thdr roach into the
even down to the definltion of general practice and a whole range of things. •
accreditation process have
come under attack. New licensing agreements issued to accrediting bodies
Medical News Editor Chns&ooker
by the RACGP will extend the power of the college to request records of all practice assessments and require cer·
Ctlnbl A . - Editor
tification of surveyors.
e.-. cannon. B.Med, IIBBS
llr (Hons), FRACGP
SWfRAndrew Bracey K1miJy Burton Oosi C«bott
Rada Rouse Art Director Rob Millington
""'"'"'-Gemma Pillars
Ql;ef S....Editor- Ed....
Martin Foster Sub-EditoriOnUne Editor Lynda Wilton
s.....uitor Robert Santos
was an attempt to take: con-
CountJy-
trol of the entire process. "This is about power and
SiaOhan Murphy
G<oup Ad...U$101 ......,.. frazer Mackenzie-Anctew
..... ..._..
O...Sc-11 Rosefulete PA - Slle$ & Mln•etmtnt ROI'I'Una Villanueva
-..&-leel'<iday
Ptoclbctionf'Deicn Auimnt S.idle(¥ C&assified Ad¥ertia.in1 Manacer Mike Mata To d•rectly oon~t staff at Medieal Observe~ email: Uifst name).(last
name.)Omedob:s.com..au
.....•.... .4
~.
•• •• •• ••
CMPMed1ca Untted Bustness Me<fta lltltbclli~UpublithedWMkl)'~ CMP~ica Auslt.Jt'l ~ t.td, ¥10
pner•
distributed rree of cf'la!te to 11'-=tltlonenand ~ Sl*k111$1$. It is •lliO ¥a~ilable on wbwiption for $350 c:>a (inct. csn and ~ntesappt,. Mt!tliclll ~IS ll"'bli!tled •a tii'M'lt )'Hr. v..-s tJ~Ptm«< . . not I'I«*Mtily thOslt of OoWMedica Auslnlia Ply Ud.. o 2008 CNPMedilct AiJstJ'Ihl '""' ltd
a d1~ ol Uwutec:t 81411"18$$ Mtcl!f,.
--·
ABN 68 050 695 I 57
ACN 050 695 157 ISSN 1445-5560
~~~~~
~ ~
PhoM: 02 t902 7771 ru: 02 t902: 7778 Website:: www.medkalobse~Wr.((lm.au Email: mallbotOtnedobs.com..au
Printed
But accreditation body Quality Practice Accreditation (QPA), which runs GPA Accceditation Plus, bas refused to sign a license to use the standards, arguing that the roles of setting and enforcing standards should remain separate. QPA managing director Dr Paul Mara has criticised the RACGP foe what he said
btt Olfwt AJpne,
'2 8oorN St.lidc:ombe: NSW 2141
"This is about power and control" Dr Paul Mara
will improve the process of scandards development [and] further support the model of peer assessment," he said.
However, Perth GP and health industry consultant Dr joe Kosterich echoed QPA's call for the setting and policing of standards to remain separate and questioned the need foe licensing agreements.
Previously, copies of the college guidelines for practice accreditation were sold on to acccediting bodies and used to independendy assess practices for compliance. However.
Australian
General Practice Accreditation Limited (AGPAL) signed the licensing agreement last month. Its chair, Dr Richard Choong, said the agreement would "formalise" the process of accreditation. "The license agreement
"ThewholereasonAGPAL
GPs reject accreditation >from page 1 Dr Harry Imber, a Melbourne GP and staunch accreditation opponent, said the new data reinforced his decision not to rake it up. He described cbe process as "onerous•, and said the PIP
was not worth the time, money and effort involved. Bur the RACGP rejected the
was set up was to have
govemment"s general practice
some separation - people heldconcemsthat thecollege's role was to develop standards but ic was not their role to [enforce) accreditation," he said. The RACGP declined to comment on why it was now seeking the license agreements and whether it had concerns that general practice standards were not be~ properly enforced. ......,
figutes. However, it did not provide its own estimates.
The college said tbe data might have included practices not officially recognised as "general practices" under its standards. This meant d>e percentage of accreditation was distorted, and it believed true accreditation rates were closer to
~
per cent.
'-'
Performance pay for GPs 'inevitable' Sophie Blakemore DOCTORS could receive higher Medicare rebates as well as pelformance incentives under a proposed model to tackle the burden of chronic disease. At a time when the government is reviewing the structure of the MBS, the model, created by one of the key designers of the Council of Australian Governments health reform, has won early backing of the medical profession. Under the blended payments system proposal, a new item number would enable GPs to assess and screen patients depending on the level of care needed {Aust Health Rev 2008:32(1): 76-85). Patients would be managed using existing care plan
items and greater emphasis would be placed on care plan reviews, which would be better remunerated. GPs would then receive payments lor achieving successful patient outcomes through a reformed practice incentive payments program. lead author of the paper, Professor Hal Swerissen, Dean of the Faculty of Health Sciences at La Trobe University in Victoria, said pay for pelformance was common in the UK and US and would become "an inevitable part of Australian healthcare". The paper also suggested the Commonwealth take over the running of chronic disease outpatient departments through Medicare to streamline the provision of care.
GPs would receive payments tor successful chronic care outcomes unCI« the plan.
AMA Council of General Practice chair Dr Rod Pearce pointed to the success of immunisation incentives and said the plan should be considered as part of the MBS review.
A spokesman for federal health minister Nicola Roxon said "different models for finding chronic disease care and out-patient care" would be considered as part of health reforms.
tPathology law threatens practice viability >from page 1 wide range of services via their super clinics," it said. In addition, AMA vice president Dr Gary Speck said market value should be
medicalobserver.com.au 15 February 2006
determined by what "the market is prepared to pay". As MO went to press it was unclear how the laws, if enacted, would be policed.
The legislation followed a Januai)' 2005 review into pathology services by law firm DLA Phillips Fox lor the federal government {MO, 9 September 2005).
Email: editoriaiOmedobs.com.au
letters mo
FEEDBACK
Clarifying proper market value (
""' 1 WRITE regarding Dr David Rivett's com ments in relation to the anti-kickback laws and inflated pathology rental prices constituting a kickback, a¡nd that my interpretation of " market value" is a "cavalier, blue-sky approach" (' Pathology probe set to scrutinise GP business dealings', MO, 11 June). Th e AMA, RACG P and The Austra lian Association of Practice Managers and myself argued successfull y with the Department of Health and Ageing and Medicare Australia for an appwpriate amend ment that lega lly clari fies this "blue sky" interpretation. In last week's interview I said , for illustrative purposes: "If someone pays you a million bucks for a room you ca n get a million bucks for it ... [as long as] nothing is in the lease arrangement saying they're gua ranteed even one referra I." I was making the point that the lega l definition of market value means " willing seller and wi lling buyer". This has been upheld in the High Courts and in o ur Austra lian Constitution and with Medicare Austra lia. In
U CPD situation a blight on common sense I WAS shocked this morning to find out the EMST course has not been approved to meet the criteria for the CPR component of the trienn ium. When I did the course, there were a lot of col leagues from the country, and to make them come back to the city to do a CPR refresher on top of th is is just terrible. After speaking with the RACGP, I was informed it can't allocate approval unti l the Royal Australasian College of Surgeons asks that it fulfil the CPR requirements. This is just not good enough and is a bl ight on common sense. And it amplifies GP angst towards the bureaucratisation of our profession. Dr Rhyon Johnson Cottesloe, WA
U
Don't take skills of anaesthetics for granted THE serious omission of information about what anaesthetists do for women in labour suggests how much
writetoletters
a 1973 national referendum we rejected the then-government's motion to price fi x goods or services. This means no Parliamentary laws ca n price fi x any good or service. The real reason why pathology labs pay a higher renta l is simple- convenience, and market de-regulation. A pregnant mum with three kids is more Iikely to visit the provider in the consult room next door than the one located in the next block.
this is taken for granted ('Draft maternity guidelines set for review after anaesthetist outcry', MO online, 7 June). Urgent caesarean section requires a skilled anaesthetist - full stop. This is an extremely dangerous time for mother and infa nt. Nor is epidural anaesthesia for amateurs. An accidental total spinal block can pose a life-threatening emergency within seconds of a mother being awake and well. Dr James Wi lkinson Anaesthetist (retired) Eastwood, Vic
g
The demise of solo GPs not pollies' fault
AS a mature and highly experienced solo GP, I endorse my colleague's sentiments ('For solo GPs, the days are numbered', Humerus, 11 June). The extinction of solo practice is about control by bureaucracy. We can't blame the pollies this time, they don't understand us. The only answers are emigration, retirement or stay long enough to receive our Australia Card
This is why the Government has a $230 million super cl inic program that co-locates pwviders. I do not condone kickbacks, but a fai r and level pl aying field for the little guys. Un fo rtunately this does not always support big business interests. Ironica lly, Dr Rivett's comments are mi sguided altruism. W hen GPs are able to sub-lease their consulting rooms for a proper market va lue, onl y then are they susta inable. They can then afford better infrastructure,
with the microchip. It was a lovely country, I remember. So was Iran once upon a time. Dr David Howse Beenleigh, Qld
0
BLOO DY hell, Dr Pam, you made me cry aga in! So very sad: To have taken the most talented, idealistic and altruistic people and crushed them under the weight of the gilt- laden - or should I say guilt laden - royal crown of the RACGP. . They raised the so-called standards so high that only a bureaucrat could jump the bar. Dr George Quittner Mosman, NSW
systems and people. This attracts doctors, solvi ng recru itment and retention problems. I remain bemused where there is a requirement to seek an independent valuation. Most valuers are experienced in valuing butcher shops. How many of them would know what a listed pathology lab will pay for a practice lease and what can be legitimately included and excluded ? There is a di fference. David Dahm Health & Life Pty Ltd
U Roxon blind to her own creation NICOLA Roxon cannot see the "big boogieman" of her own creation ('The debate: Roxon vs Dutton', MO online, 4 June)? That's rich. "I don't think anyone can point at a single part of our proposals that suggest that we are nationalising the health system" - that's either a recognition of her 'lack of thinking' (evident in her overall performance as a health minister), or a blatant lie and insult to our and the Australian public's intelligence. Dr Panagiota Milonas Clayton South, Vic
iPad and iPod comp winners CONGRATULATIONS to the main prize winner, Dr Genevieve Yates of Cooroy, Qld, who has won a an iPad and iPod nano. Dr Arthur Zulman of Lower Templestowe, Vic, Dr Carol McGrath of Glen Forrest, WA, Dr Mark Woo of Kogarah, NSW, and, Dr Dien Dang of Footscray, Vic have all won iPod nanos. Thanks to al l who entered!
Post: Medical Observer, Locked Bag 3000, St Leonards, NSW 1590 E-mail: mailbox@medobs.com.a u Fax: 02 9902 7778 Website: www.medicalobserver.com.au Letters should be no longer than 200 words and must include contact details.
1a JuNE 201 0
8BSERVER
25
~ inbrief
Oestrogen an aid in psychosis
'--'
Rada Rouse PIONEERING
Safety concerns over COPD treatment CONCERNS have been raised over the safety profile of the COPO treatment tiolropium (Spiriva), after a review linked its use to a possible increased risk of stroke. The US Food and Drug Administration (FDA) has asked the manufacturer, Boehringer lngelheim, to supply more information. The company recently informed the FDA that it had analysed safety data from 29 placebo controlled studies of products containing tiotropium
Australian
research suggests exogenous
oestrogen may be a useful adjunct to treatment with
Congress on Women's Mental Health in Melbourne last week preliminary results from her srudy of 102 "floridly psychotic" women aged 27
antipsychotic medication in women with schizophrenia.
'It might help improve quality
Researchers from the Alfred Psychiatry Research Centre, Melbourne, demonstrated
of life'
faster and better resolution of symptoms in women using
48 years had fou nd some dramatically improved in the
adjunctive 100 meg tra nsdermal oestradiol compared with women on antipsychotic med-
treatm ent arm.
ication alone.
The
centre's
director,
Professor Jayashri Kulkarni, told the 3rd International
to
On entry to the trial the women scored an average 84 points in severiry of hallucinatory and delusional symptoms, with the oestradiol group dropping an average 32
points compared to an average 14 points in the placebo group over four weeks (Arch Gen Psychiatry in press). "This is statistically significant... and it makes the difference between [a woman] being an inpatient and being out of hospita l,,, Professor
Kulkarni said. She added accumulating evidence showed many women were presenting with psychotic symptoms in the postpartum or perimenopausal periods. "Women who have estab-
lished psychosis often notice that they are worse in the premenstrual week," she added.
Clinical observations indicated thar women who continued with adjunctive oestrogen following the completion of trials were able to reduce their antipsychotic medication. While amipsychotics reduced hallucinatory and delusional symptoms, they often had the effect of "numbing" the emotions, but this did not occur with oestradio l, sug-
gesting it might help improve qualiry of life, she said. Professor Kulkarni's group was also testing raloxifene and
tamoxifen in treating schizo-
phrenia and bipolar disorder respectively. ,....,
bromide, used for maintenance
treatment of bronchospasm and dyspnoea associated with COPD. The analysis, involving
13,500 patients, showed that preliminary estimates of stroke risk were eight patients per 1000 treated for a year with tiotropium, compared to six patients per 1000 on a placebo. Aspokesman for Boehringer Jngelheim Australia said the company and partners Pfizer concurred with the FDA statement and were voluntarily providing information to the FDA and the TGA. However, he emphasised that the FDA "has not reached a conclusion about whether this information warrants any regulatory action".
GP cautioned over
'inadequate' records A VICTORIAN GP has been given a caution for failing to keep medical records for two of his patients for up to eight years. Dr Peter lisdall was ordered by the Medical Practitioners Board of Victoria to attend performance assessment, training and monitoring to ensure he kept adequate clinical notes in future, after it foun d his records were inadequate and, in some instances, contained only a date stamp relating to a consultation. The board also investigated allegations that Dr lisdall, a rural GP in Kyabram, caused or aggravated a dependency on pethidine in one female patient. While the board was unable to conclude whether Dr lisdall caused the dependency, prescribing the drug for such a long period was not good medical practice, it said. However, the board did acknowledge Dr lisdall had little other option "in a rural setting".
Govt backdown on pathology law Andrew Bracey IN a victory for the profession, the federal government has backflipped on laws regarding leasing agreements between general practices and pathology providers following concerns practices could go out of business. The legislation, which came into effect on 1 March, stipulates practices charging above market value for co-
located services face fines of up to $600,000 and jail terms (MO, 15 February). But in a letter to the AMA, the federal health department has backed down and agreed to clarify its definition of 'market value' to reflect
the highest offered bid by a service provider for practice space in an open tendering
process. According to the letter obtained by MO, pathology provider proximiry to a "source
of referrals" would
also no longer need to be excluded as a factor in determining market value. Practice management specialist David Dahm, who voiced industry concerns to
the department, congratulated the government for listening. Mr Dahm said the changes meant practices could now include practice infrastructure, equipment, fittings, staff and corrunon areas in open
tendering evaluations. "To some extent it reverses
[the legislation] and creates more opportunity," he said. Australian Association of Practice Managers vice-
president Brett McPherson said the changes should not interfere with existing lease agreements or create require¡ ments for practices to gain new evaluations.
G
Folate decreases sperm abnormalities Kirrilly Burton US researchers have linked increased folate intake to reducing human sperm aneuploidy, a condition that may account for over a third of spontaneous abortions. In a study of 89 men, they found lower overall frequencies of aneuploid sperm in men with higher micronutrient intake. Previous studies had shown there was a high paternal contribution to sex chromosome aneuploidies, the most frequent numerical chromosomal
abnormalities in humans at birth. The researchers argued that if their find ings were replicated by other studies, "a possible public
health intervention would be to increase folate intake for men considering fatherhood". Professor Robert Mclachlan, director of Andrology Australia, agreed that if an interventional study demonstrated that folic acid did relate to sperm aneuploidy, and that supplementation decreased aneuploid sperm levels, it "could potentially have significant implications for public health fertility". The men with high folate intakes -over 722 ~g. 1.8 times the recommended daily amount - had 20% lower levels of sperm aneuploidy compared to men with low folate intakes (! 14-333
~g),
the researchers said (Human
Reproduction, in press).
However, Professor Mclachlan said there were problems with the study, in particular its small sample size and the use of a questionnaire to analyse food intake. ANZAC Research Institute director Professor David Handelsman agreed, saying the study used a relatively small sample of volunteers, with normal sperm counts, who might not represent a typical population of men in the community. "The significance of this observational study is uncertain, and it is not a reason to start any dietary interventions," he added.
medicalobserver.com.au 28 March 2008
letters have your say - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Planned lease law misguided EDITOR: Some of the inappropriate practice laws ('Pathology law threatens practices', MO, 15 February) can be best described as misguided altruism. Many innocent, law-abiding arrangements such as pathology leases will come under unwarranted scrutiny and possible prosecution. At worst, this may be the beginning of the legislative destruction of independently owned general practice in Australia. The clear message to G.Ps is don't invest in your practice infrastructure,
let the corporares and government own you and run you.
I'd be worried about spending $30,000 on a renovation, or building a S30 million super clinic, if the proposed kickback regulations are passed in their "discussed" form. lf the new legislation deems (after rwo government-directed independent valuations) that the rent you receive from a co~locared radiology or pathology tenant is above the government's "mar-
ket value", then the lease needs to be renegotiated before March 2008 or you may face big fines or a stint in jail if you are a doctor, practice manager or professional adviser. Anyone directly or indirectly involved can be prosecuted.
For example, if you're receiving pathology rent at $500 sqm, and the local fish and chip shop owner can only pay $200 sqm for a non-medical use government-deemed "marker" rene, then you have prohibited lease. The government will impose a blunt instrument valuation process and substitute this for the marker price, which is now achieved when practices put
their premises our to tender. When there is one willing seller and rwo or more willing buyers, you technically and legally have the real market value of a lease.
The clear mess<1ge is don't inve~t in vour practice mfrastructure The legislation is potentially unconstitutional. In 1973, a national referendum decided against the government setting prices. If you want to recruit and retain doctors and improve patient outcomes, you need to stan building large multidisciplinary integrated primary healthcare practices. However, this legislation threatens this government mandate.
Today, rhey target diagnostics arrangements. Tomorrow, is it pharmacy? The day after, GPs and
specialists who inter-refer to each other? Is this how disgruntled tenants get a rent reduction, by com¡
plaining ro authorities, making kickback claims? What I find perplexing is why corporates are exempted. They can use their large pathology profirs to buy out doccors at a premium without fear
of prosecution. The legislation gunrantees the third mouth ro feed from the same consult fee in the consulting room is well looked after. The profession should continue to own the family home and not rent ir. Encouraging third par¡ ties 10 own and run practices is promoting a gypsy medical workforce of all care and no responsibility. David Dahm CEO, Health & Life
more letters... Sagan's demon fast approaches
skin n. permanent prod uct packaging that human beings come in. It is colour coded for greater ease in knowing who to blame.
write to letters Post: Medical Observer, Locked Bag 3000, St Leonards, NSW 1590 E-mail: mailbox@medobs.com.au Fax: 02 9902 7778 Website: Click on 'have your say' icon at www.medicalobserver.com.au Letters should be no longer than 200 words and must include contact details. medicalobserver.com.au 22 February 2CXl8
EDITOR: Dr Rob Walters from MIPS ('Defensive practices', 25 January) makes it quite clear: the threat of litigation mandates inappropriate clinical practice. Presumably he agrees with Professor John Murtagh that best clinical practice includes "not doing certain things", after explaining why to the patient. However, Dr Walters trumps the good professor because "community expectations demand defensive medicine" and "it's not going to look good in court". Judicial expectations and community ignorance are obviously a potent brew, a poisoned chalice which cannot be refused. Unless this can be sorted out at the highest levels, where doctors as guardians of limited financial resources are respected, and "doing everything to everybody" is positively condemned, organisations such as the medical boards and the
Professional Services Review may have difficulty investigating the country's "most prolific orderers" of any test, or indeed providers of clinical services. Carl Sagan must be turning in his grave. Welcome back to the demon-haunted darkness. Dr Warwick Ruse, FRACP Cannington, WA
Changes to Medicare must be universal EDITOR: I read Nicola Roxon is "definitely keen ... to ensure there is no financial disincentive to providing quality care" (MO, 14 December). If she implements seven time tiers, it will not be a fundamental change like Medicare Plus, which applies universally to all providers, introduced by the previous health minister, and it remains to be seen if seven time tiers will make any difference in patient outcome. Let us hope Ms Roxon will be able to make fundamental changes in Medicare that apply
universally, leading to further improvement in patient outcome. Dr Ratnakar Bhattacharyya St lves, NSW
Base guidelines on evidence, not culture THE argument that the latest NHMRC guidelines on safe alcohol consumption are unlikely to be followed as they are not socially realistic (MO, 8 February) is strange logic in my opinion. I would have thought that all guidelines promoted by our noble profession should be evidencebased and not on what is deemed culturally normal. Asignificant number in our community don't adhere to the legally enforced recommendation to drive with a blood alcohol level of under 0.05. Because of this, perhaps we should lift the permissible level so that it is more in line with societal norms? To me this would seem equally illogical. Dr Paul Wood Gunnedah, NSW
~ inbrief
Oestrogen an aid in psychosis
'--'
Rada Rouse PIONEERING
Safety concerns over COPD treatment CONCERNS have been raised over the safety profile of the COPO treatment tiolropium (Spiriva), after a review linked its use to a possible increased risk of stroke. The US Food and Drug Administration (FDA) has asked the manufacturer, Boehringer lngelheim, to supply more information. The company recently informed the FDA that it had analysed safety data from 29 placebo controlled studies of products containing tiotropium
Australian
research suggests exogenous
oestrogen may be a useful adjunct to treatment with
Congress on Women's Mental Health in Melbourne last week preliminary results from her srudy of 102 "floridly psychotic" women aged 27
antipsychotic medication in women with schizophrenia.
'It might help improve quality
Researchers from the Alfred Psychiatry Research Centre, Melbourne, demonstrated
of life'
faster and better resolution of symptoms in women using
48 years had fou nd some dramatically improved in the
adjunctive 100 meg tra nsdermal oestradiol compared with women on antipsychotic med-
treatm ent arm.
ication alone.
The
centre's
director,
Professor Jayashri Kulkarni, told the 3rd International
to
On entry to the trial the women scored an average 84 points in severiry of hallucinatory and delusional symptoms, with the oestradiol group dropping an average 32
points compared to an average 14 points in the placebo group over four weeks (Arch Gen Psychiatry in press). "This is statistically significant... and it makes the difference between [a woman] being an inpatient and being out of hospita l,,, Professor
Kulkarni said. She added accumulating evidence showed many women were presenting with psychotic symptoms in the postpartum or perimenopausal periods. "Women who have estab-
lished psychosis often notice that they are worse in the premenstrual week," she added.
Clinical observations indicated thar women who continued with adjunctive oestrogen following the completion of trials were able to reduce their antipsychotic medication. While amipsychotics reduced hallucinatory and delusional symptoms, they often had the effect of "numbing" the emotions, but this did not occur with oestradio l, sug-
gesting it might help improve qualiry of life, she said. Professor Kulkarni's group was also testing raloxifene and
tamoxifen in treating schizo-
phrenia and bipolar disorder respectively. ,....,
bromide, used for maintenance
treatment of bronchospasm and dyspnoea associated with COPD. The analysis, involving
13,500 patients, showed that preliminary estimates of stroke risk were eight patients per 1000 treated for a year with tiotropium, compared to six patients per 1000 on a placebo. Aspokesman for Boehringer Jngelheim Australia said the company and partners Pfizer concurred with the FDA statement and were voluntarily providing information to the FDA and the TGA. However, he emphasised that the FDA "has not reached a conclusion about whether this information warrants any regulatory action".
GP cautioned over
'inadequate' records A VICTORIAN GP has been given a caution for failing to keep medical records for two of his patients for up to eight years. Dr Peter lisdall was ordered by the Medical Practitioners Board of Victoria to attend performance assessment, training and monitoring to ensure he kept adequate clinical notes in future, after it foun d his records were inadequate and, in some instances, contained only a date stamp relating to a consultation. The board also investigated allegations that Dr lisdall, a rural GP in Kyabram, caused or aggravated a dependency on pethidine in one female patient. While the board was unable to conclude whether Dr lisdall caused the dependency, prescribing the drug for such a long period was not good medical practice, it said. However, the board did acknowledge Dr lisdall had little other option "in a rural setting".
Govt backdown on pathology law Andrew Bracey IN a victory for the profession, the federal government has backflipped on laws regarding leasing agreements between general practices and pathology providers following concerns practices could go out of business. The legislation, which came into effect on 1 March, stipulates practices charging above market value for co-
located services face fines of up to $600,000 and jail terms (MO, 15 February). But in a letter to the AMA, the federal health department has backed down and agreed to clarify its definition of 'market value' to reflect
the highest offered bid by a service provider for practice space in an open tendering
process. According to the letter obtained by MO, pathology provider proximiry to a "source
of referrals" would
also no longer need to be excluded as a factor in determining market value. Practice management specialist David Dahm, who voiced industry concerns to
the department, congratulated the government for listening. Mr Dahm said the changes meant practices could now include practice infrastructure, equipment, fittings, staff and corrunon areas in open
tendering evaluations. "To some extent it reverses
[the legislation] and creates more opportunity," he said. Australian Association of Practice Managers vice-
president Brett McPherson said the changes should not interfere with existing lease agreements or create require¡ ments for practices to gain new evaluations.
G
Folate decreases sperm abnormalities Kirrilly Burton US researchers have linked increased folate intake to reducing human sperm aneuploidy, a condition that may account for over a third of spontaneous abortions. In a study of 89 men, they found lower overall frequencies of aneuploid sperm in men with higher micronutrient intake. Previous studies had shown there was a high paternal contribution to sex chromosome aneuploidies, the most frequent numerical chromosomal
abnormalities in humans at birth. The researchers argued that if their find ings were replicated by other studies, "a possible public
health intervention would be to increase folate intake for men considering fatherhood". Professor Robert Mclachlan, director of Andrology Australia, agreed that if an interventional study demonstrated that folic acid did relate to sperm aneuploidy, and that supplementation decreased aneuploid sperm levels, it "could potentially have significant implications for public health fertility". The men with high folate intakes -over 722 ~g. 1.8 times the recommended daily amount - had 20% lower levels of sperm aneuploidy compared to men with low folate intakes (! 14-333
~g),
the researchers said (Human
Reproduction, in press).
However, Professor Mclachlan said there were problems with the study, in particular its small sample size and the use of a questionnaire to analyse food intake. ANZAC Research Institute director Professor David Handelsman agreed, saying the study used a relatively small sample of volunteers, with normal sperm counts, who might not represent a typical population of men in the community. "The significance of this observational study is uncertain, and it is not a reason to start any dietary interventions," he added.
medicalobserver.com.au 28 March 2008
Testing times - Legal and Business -Medical Observer
Page 1 of2
Testing times Friday, 26 June 2009
Doctors' arrangements with pathology and imaging providers are under new scrutiny, but how can
the Medicare microscope? Mandy Bryan reports. DESPITE the introduction of tough new laws last year aimed at deterring doctors from developing unhealth>y relationships with pathology and diagnostic service providers, Medicare Australia thinks doctors may be pu hip pocket first when deciding where to refer their patients.
It's launched yet another investigation into claiming data- this time trying to identify ~possible referral rela between doctors and providers which could indicate that the doctor's desire for a healthy dividend is outwe professional judgement when it comes to the best service provider for that particular test.
If it's found to be true the doctor could be on the wrong side of the law as any payments received could be to be a reward for sending patients to a provider- especially if the payments are in proportion to the volurT patients. Medicare's review is in its very early stages and involves the analysis of some complex claiming data, accor general manager of its program review division, Colin Bridge. "For this reason, we cannot provide further details at this stage,H he says. Last year's amendments to the pathology and diagnostic imaging laws- the Health Insurance Amendment (Inappropriate and Prohibited Practices and Other Measures) Act 2007- sought to extend an existing ban o financial kickbacks to include non-financial incentives such as hospitality, staff, equipment and rents paid ; percentage of referrals (see Things you can't do). For those who get caught In its cross hairs, tough new criminal and civil penalties apply (see Penalties). WHAT IS LEGAL? Even under the new laws, it is legal for doctors to own shares in and/or create a joint venture with a diagno or pathology company. A ban of such arrangements would have significantly impacted those corporate operators who vertically int clinics and diagnostic services because GPs are usually issued shares in the company as part of the deal. Instead, the new laws provide stipulations around these relationships, with the main change being that ben relationship can't be linked to the volume of referrals and must be In proportion to the interest held. That means that If a doctor receives a distribution of profits or shares from the operation of a pathology or imaging business, the amount of the benefit must be in proportion to their financial interest in the busines If they receive remuneration as an employee, it must not be substantially different from the usual remunerc someone in similar employment. And payment for property, goods or services shared between a doctor and another person must be pro port other person's share of the cost of the property, goods or services. But until Medicare's review is finalised some time in the coming months, it's still unclear how much of an is financially motivated referral patterns are. Both the new Jaws and Medicare's latest investigation follow unease among health authorities about averse its associated impacts, reduction in patient choice, and creation of an uneven playing field in the industry. FINANCIAL PRESSURES And of course there's the financial pressure on Medicare as costs for diagnostic Imaging and pathology ser Last financial year those costs together totalled $3.6 billion, double that of 10 years ago. Some of this can be explained by the trend towards a more defensive style of practice. However, if US trends are any indication, the potential remains for doctors to succumb to financial interests engaged in legal business arrangements with those to whom they refer patients. In the us diagnostic costs have also risen substantially in certain states, and authorities have partly attribut increase to financial incentives. But there still is no hard evidence that this is occurring in Australia. According to Mr Bridge, it is impossible the impact financial incentives may be having on overall claiming of diagnostic imaging benefits under Med is hoped the review wiiJ shed some light on the area. He also notes a referral may stiiJ be legitimate even where a financial incentive is involved. According to Andrew Took, national manager of medico-legal advisory services at Avant, the important poi that any referral should be clinicatJy justifiable, and that should be readily ascertainable in the GP's notes. Mr Took says Medicare "has sophisticated scanning tools" that can pick up overservicing, therefore he sugg worth considering using 2-3 providers to dispel any impl!cation of favouritism or incentives".
http://www .medicalobserver. com. au/Legal/0, 1734,4 78 3,26200906 .aspx
31/08/2009
Testing times - Legal and Business -Medical Observer
Page 2 of2
One argument is that aligning the interests of doctors to the bottom lines of these companies alone could I influence referral patterns. Former AMA president Dr Rosanna Capolingua said last year that the association had always been "very con any vertical integrative process in the delivery of healthcare where there can be one owner of a general pra1 pathology or radiology provider and there could be incentives in that vertical integration for doctors to refe JOINT VENTURE CONCERNS ---
The CEO of the Royal Australian and New Zealand College of Radiologists, Don Swinbourne, also has conce1 with regard to joint venture arrangements between doctors and providers of radiology services due to the r overservicing.
"As far as we are concerned, specialist services need to be at arm's length," he says. "That means the referr influenced by factors other than the skills of specialists. "That is not to say a particular doctor would do that, but how you monitor that is difficult." According to David Dahm, CEO of practice management consultancy Health & life, a solo GP with a largest listed diagnostics firm would have little impact on profits and therefore be unlikely to be swayed on that ba a group practice that owned shares could well be, despite a lack of evidence to show that is the case. According to Mr Took, most queries from GPs regarding the new laws have come in relation to another issu accepting a lease at reduced market rents would be in breach of the legislation. "My advice is to make sure you get an independent valuation, to ensure that the rent is set at market value, Mr Took urges those entering into financial arrangements with a diagnostic or pathology company to get ir accounting and legal advice to ensure that it is a legitimate commercial transaction that does not offend th• He adds that any doctors contacted by Medicare regarding concerns over unnecessary ordering of patholog diagnostic imaging tests should seek advice from their medical defence organisation.o Penalties A person convicted of a criminal offence under the prohibited practice provisions may be subject to; up to five years' imprisonment. • An Individual found to have committed a civil contravention may be subject to a penalty of up to $66 the penalty rising to a maximum of $660,000 for a corporation. A provider suspected for overservicing of diagnostic images can be referred to the Professional Servl and, If found to have practised Inappropriately, can be suspended from claiming Medicare benefits fc years. Things you can't do • Receive any benefit related to the number, kind or value of requests for diagnostic Imaging or pathol • Provide staff or equipment at the premises of another person for the purposes of providing diagnost pathology. Provide property, goods or services on terms that are substantially different from the market value. ~---~---~
More Stories Medical News» Govt stands f1rm on multidose vials for swine flu vaccine New safety concerns over folic acid
Professional News » Maternity nurses seek access to child checks NT Government amends sex reporting Jaws
Clinical Review » Falling fertility? Fingers point to diagnosis
Registrar» Keeping the country on the radar Palliative care boom
Update» The acute leukaemias: Part 2 The acute leukaemias: Part 1
Legal and Business» The current state of play on indemnity Taking care of business: how do you choose a policy?
©Copyright 2008 CMPMedica, All rights reserved.
http://www.medicalobserver.com.au!Legal/0,1734,4783,26200906.aspx
31/08/2009